Assessment report on Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum

Clinical Efficacy

Therapeutic use of anise alone is not substantiated with human clinical trials.

1. Dose response studies

There are no dose-finding studies available.

The recommended dosage for adults and children over 12 years is supported by clinical experience and expert opinions (British Herbal Pharmacopoeia, 1983; Blumenthal et al., 1988; Czygan & Hiller, 2002; Dorsch et al., 2002).

2. Clinical studies (case studies and clinical trials)

• 
  Secretolytic and expectorant effects
  

A combined herbal preparation containing dry ivy leaf extract as the main active ingredient, a decoction of thyme and aniseed, and mucilage of marshmallow root was investigated in an open clinical trial for its effects on the symptoms of cough and its tolerability. The trial was carried out on 62 patients with a mean age of 50 years (range 16-89) with irritating cough in consequence of common cold (n = 29), bronchitis (n = 20) or respiratory tract diseases with formation of viscous mucus (n = 15). The mean daily intake was 10 ml (range 7.5-15) of syrup, and the mean duration of treatment was 12 days (range 3-23 days). All symptom scores showed an improvement as compared to baseline (Buechi et al., 2005).

• 
  Combinations
  

Randomised clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation
The laxative efficacy of a phytotherapeutic combination containing Pimpinella anisum L., Foeniculum vulgare, Sambucus nigra L., and Cassia angustifolia largely used in Brazil for the treatment of constipation has been tested in a randomised, crossover, placebo-controlled, single-blinded clinical trial including 20 patients with chronic constipation according to the criteria of the American Association of Gastroenterology. Half of the subjects received the combination for a 5-day period, whereas the other half received placebo for the same period. Both treatment periods were separated by a 9-day washout period followed by the reverse treatment for another 5-day period. The primary endpoint was colonic transit time (CTT), measured radiologically. Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life. Mean CTT assessed by X ray was
15.7 hours (95%CI 11.1-20.2) in the active treatment period and 42.3 hours (95%CI 33.5-51.1) during the placebo treatment (p < 0.001). Number of evacuations per day increased during the use of active tea; significant differences were observed as of the second day of treatment (p < 0.001). Patient perception of bowel function was improved (p < 0.01), but quality of life did not show significant differences among the study periods. Except for a small reduction in serum potassium levels
during the active treatment, no significant differences were observed in terms of adverse effects throughout the study period. The authors concluded that the combination assessed has laxative efficacy and is a safe alternative option for the treatment of constipation (Picon et al. 2010).

Open pilot study of a herbal tea mixture on allergic asthma

An open pilot study was carried out with a herbal tea mixture of eight herbs including anise (2.5 g each of powdered anise, fennel and caraway fruits, 7.5 g powdered chamomile flowers, 0.3 g each of powdered licorice roots and saffron flowers, 2.5 g and 1.3 g of freshly ground cardamom and Nigella sativa seeds).The mixture had the same composition as the water extract used to test the in vitro inhibitory effect on histamine released from rat peritoneal mast cells stimulated either by compound 48/80 or by IgE/anti-IgE (see section 3.1.). Forty female patients, aged 30 to 50 years, suffering from allergic asthma, taking the antihistaminic drug ketotifen, 1 mg twice a day, plus the selective β₂ stimulant salbutamol, 2 mg once a day, were divided into two groups of twenty each: Group I taking one cup of the herbal tea mixture twice daily and Group II taking regular tea of Camellia sinensis as an active placebo. The antihistaminic medication was reduced to one daily in all patients. The clinical results reported by the authors showed significant improvements of sleep discomfort, cough frequency and cough intensity in addition to increased percentages of FEV1/FVC in patients suffering from allergic asthma, who used the herbal tea compared to those who used the placebo tea (Haggag et al., 2003).

3.